Drug Approval | September 21, 2023
USFDA conducts inspection at InvaGen manufacturing facility in Central Islip, NY, USA
InvaGen has received 5 inspectional observations in Form 483
InvaGen has received 5 inspectional observations in Form 483
The inspection was a cGMP Inspection and had ended with NIL observations
The company will develop and produce premixes for human nutrition applications
The facility has a potential for capacity expansion up to 2 billion tablets/capsules per year
Exothera will manufacture Meissa’s MV-012-968 vaccine candidate under CGMP regulations to supply Phase 2 clinical trials
Under the terms of the collaboration, Vertex and Lonza will partner in the process development and scale-up for the manufacturing of the product portfolio and co-invest to build a dedicated new facility in Portsmouth, New Hampshire (US)
Carbogen Amcis Manchester won the industry award in recognition of its efficiency improvement program implemented in response to increased demand for its products
The inspection closed with the facility receiving an inspection classification of NAI
The company will submit its comprehensive response on these observations to the US FDA
Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing for a multi-product biosimilars portfolio
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